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Drug/Device Combinations: How To Harness Global Regulatory Efficiencies

In this interview, Arkan Zwick, regulatory affairs director at Croma Pharma, talks about the global picture for regulation of device-type drug/device combination products. Regulatory requirements for these products for are among the most demanding and costly. Zwick discusses opportunities to utilize existing testing and maximize efficiencies on a global scale.

Combination Products Regulation Medical Device

Latest Mako Tech Fleshes Out Stryker's Robotic Joint Replacement Line But Cost Critics Still There

Stryker launched the Mako robotic arm-assisted total knee arthroplasty system at last week's AAOS annual meeting, making the company the first to offer a surgical robotic technology that covers the total knee, partial knee and total hip replacements. Critics, however, say the clinical outcomes do not necessarily justify the costs. Meanwhile, Stryker's orthopedic rivals, Zimmer Biomet and Smith & Nephew, also sought to highlight their own robotic offerings.

Orthopedics Surgery Companies

CMS Administrator Seema Verma: What Industry Can Expect

The Senate confirmed former health-policy consultant Seema Verma as administrator of the US Centers for Medicare and Medicaid Services earlier this month, and she was sworn in March 14. Medtech Insight took a look at some of Verma's policy positions affecting industry, including potential changes to accountable care organizations, appropriate-use criteria, the Centers for Medicare and Medicaid Innovation, lab payments, and telehealth services.

Reimbursement Legislation Policy

Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former US FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices – including FDA's in-the-works "program alignment" inspection initiative, may affect your facility audits. Also discussed: the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).

Quality Control Compliance Quality
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Policy & Regulation Explore this Topic

Set Alert for Policy

Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.

Combination Products Policy Regulation

Diagnostics Reg Overhaul Floated In US House

Lawmakers are circulating draft legislation that would create a new regulatory category, distinct from medical devices, combining in vitro diagnostics and laboratory-developed tests. The representatives say they don't have specific timing in mind for moving the bill forward. But it is being circulated just as the FDA user-fee reauthorization process is getting off the ground, presenting a possible legislative vehicle.

In Vitro Diagnostics FDA Legislation

'Low-Hanging Fruit' Of Industry Comms Policy Addressed By Recent FDA Documents

Draft guidance documents issues by US FDA in January did not tackle the toughest off-label speech debates, but they did provide some useful information to guide company communications, experts said on a recent FDLI webinar.

Regulation Advertising, Marketing & Sales

Number To Know…3

Only three leadless pacemakers have been CE marked to date, as revealed following the publication of recent UK guidelines on how to evaluate such products.

Cardiology Regulation

Risks Of Missing Reauthorization Deadline Highlighted At User-Fee Hearing

FDA center directors, including device chief Jeffrey Shuren, told lawmakers they are committed to reauthorizing user-fee programs during a March 21 Senate hearing. The officials wouldn't comment on a recent budget proposal from the Trump administration that seeks more user fees and less appropriations from Congress that industry agreed to.

Policy Regulation

With ENVI's 'Yes' Vote, EU Regs Could Come Into Force As Early As Mid-May

The European Parliament's ENVI Committee has given the nod of approval to the latest versions of the Medical Devices and IVD Regulations, which means the new rules could take effect as early as two months from now, or by early June.

Europe Regulation

CMS Pushes Back Cardio, Ortho Bundled-Pay Models

Trump's new CMS Chief Seema Verma has only been in place for a week, but an agency decision to delay implementation of two bundled-payment initiatives – one on cardiac care and one on joint replacements – underscores the administration's wariness of mandatory value-based payment models.

Cardiology Orthopedics

UK Guidance On Leadless Pacemakers Is A Prelude To Requirements Under EU MDR

New UK guidance on the clinical evaluation of leadless cardiac pacemakers provides useful advice on ranges of patient size for clinical studies and minimum data points.

United Kingdom Regulation

Quality Control Explore this Topic

Latest From Quality Control

Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former US FDA investigations branch director Ricki Chase explains how your firm can best respond to the agency following the issuance of an FDA-483 inspection form, and tells you four things your firm should never do when replying to FDA.

Quality Control Compliance

Compliance 360° Part 5: Medical Device 483s – US FDA's Top 5 Observations

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms, including failing to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product.

Quality Control Compliance

US Regulatory Reads, February: Compliance, Gorsuch And Executive Orders

The 10 most popular Medtech Insight stories in February on a US regulatory theme included our Compliance 360° podcast series, continued coverage on the impact of President Trump's executive orders on US FDA oversight, and an assessment of the potential impact of Neil Gorsuch, who has been nominated to fill the opening on the US Supreme Court.

Quality Control Regulation

Commercial Explore this Topic

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Lack Of Monetization Know-How Hits Price Margins For Medtech

One in five medtech companies in Europe feel they are not capable of fully monetizing innovations they are putting out into the marketplace, according to Simon-Kucher & Partner's latest "Medtech Barometer" report. Subsequently, firms are not offsetting losses arising from persistent price erosion, and this is impacting profit growth, the survey findings suggest.

Business Strategies Growth Commercial

Latest From Commercial

$50m In New Capital Could Help Moximed Spring Into US Earlier

In its latest and biggest fundraising to date, Moximed has bagged $50m in a series C round, which will help the company take its joint-unloading technology for osteoarthritis patients through US approval and into early commercialization.

Orthopedics StartUps and SMEs

New Chronix Liquid Biopsy Test Could Save Doctors On Immunotherapy Costs

Chronix Biomedical continues to demonstrate the potential of its blood-based cancer test across a growing range of indications – this time, its ability to help doctors assess how well patients are responding to immunotherapy, at an earlier stage than current diagnostic imaging methods.

Cancer Innovation

Symetis Seeks $60m IPO To Make A Splash In Structural Heart

Symetis, Europe's No. 4 in the TAVR market, hopes its initial public offering, with a price range of €26 to €32 per share on Euronext Paris, will help build on its recent transcatheter mitral valve repair acquisition and its growing market position in TAVR.

Cardiology Financing

GE Healthcare Patches In Wireless Fetal Monitoring Device

GE Healthcare has snapped up Novii, a wireless fetal monitoring device, as part of its acquisition of UK-based company Monica Healthcare. GE Healthcare aims to expand distribution of the wireless device, which is currently only available in the US.

Diagnostics M & A

Device Week – Mar. 17, 2017

On this week's Medtech Insight podcast: President Trump releases budget "blueprint" calling for cuts in many US agencies, including FDA; class II designations formalized by FDA for a slew of important products; FDA proposes exempting from 510(k) requirements hundreds of class II devices; a new surgical robotic project wins a €4m grant from European Commission; an update from the American College of Cardiology annual scientific sessions.

FDA Medical Device

Could The City Hospitals Project Be A Bit Of A Turkey?

As Turkey’s City Hospitals project goes underway, with the first few hospitals already up and running, big medtech players are swooping down to capitalize on this opportunity which promise to boost the Turkish market by up to TRY2bn. However, intense competition, as well as basic problems that had been plaguing companies operating in that country, persists and still needs to be resolved.

Turkey Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R

Pulse Biosciences' Shoots For US Clearance Of Nano-Pulse Platform

Pulse Biosciences' nano-pulse technology, PulseTx, precisely targets and kills cells with short electrical pulses that induce cell death and induce an immunogenic response. The company has submitted a 510(k) application to the US FDA for the technology, seeking a broad soft-tissue ablation indication, but it is developing PulseTx for immunoncology and dermatology indication.

Cancer ImmunoOncology Clinical Trials

Latest From Research & Development

SURTAVI Supports Intermediate-Risk Intervention For Medtronic's CoreValve

In an interview with Medtech Insight, the lead investigator of SURTAVI, an ongoing trial of Medtronic's CoreValve in intermediate risk patents, says transcatheter aortic valve is continuously improving and will probably soon be indicated for even low-risk patients, but that surgical valve replacement will have an important role to play for the forseeable future.

Cardiology Clinical Trials

When Surgical Robotics Become Wearable

A 10-partner research project has won a €4m EU grant to develop a wearable surgical robotic system, the first of its kind. The leader of the project, Sanja Dogramadzi of the Bristol Robotics Laboratory, provided more details on how this new technology would improve on existing systems like Intuitive Surgical's leading da Vinci.

Surgery Innovation

Starts & Stops: Boston Scientific Starts, Stops, And Finishes TAVR Trials

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. This month's edition includes seven trial-terminations – not as many as last month, but more than usual – for a variety of reasons, including Boston Scientific's suspension of all its trials of the Lotus transcatheter aortic valve due to a manufacturing problem.

Clinical Trials Research & Development

OUS Approvals Analysis: Medtronic Records Another Stack Of Overseas Approvals

With 28 approvals, including 22 CE Marks, February 2017 was the biggest month for non-US medical device approvals on Medtech Insight’s Approvals Tracker since June last year, which had 31 approvals including 27 CE Marks.

Approvals Innovation

Device Week – March 10, 2017

On this week's podcast, we discussed a controversial modification to FDA's definition of "intended use," patent issues with Boston Scientific’s Lotus valve, the Republican bill to replace the Affordable Care Act and some disappointing clinical trial data that was presented at the annual Society of Interventional Radiology conference.

Device Week Medical Device

Not Too ATTRACTive Data For Catheter Thrombolysis In Combatting Post-Thrombotic Syndrome

Randomized trial results show pharmacomechanical, catheter-directed thrombolysis does not reduce the development of post-thrombotic syndrome in patients treated for deep-vein thrombosis. The study’s investigator suggests limiting the procedure to treatment of large iliofemoral blood clots causing major symptoms in patients who are at low risk of bleeding.

Cardiovascular Clinical Trials
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